Director of Manufacturing – Cell Therapy
Natick, MA • Full Time
HebeCell is searching for a Director of Manufacturing to lead our Manufacturing Operations team. The person will be responsible for GMP facilities operations for our preclinical and phase I GMP manufacturing facility. The person will recruit, manage, and develop the Manufacturing Operations team to support daily operations of the cGMP manufacturing facility.
The ideal candidate is creative, team oriented and has hands on experience in all aspects of manufacturing operations related to operating a GMP manufacturing facility. The candidate will have relevant background in Cell Therapy Manufacturing. The Director will be responsible for leading the day-to-day operations of cell therapy manufacturing. The role will also be a key contributor to the implementation and execution of the HebeCell quality system including oversight of facility and equipment validation activities, responsible for the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of site operations to global GMP regulations. Experience in start-up and operation of GMP clean utilities and manufacturing facilities is a plus. The Director reports to the VP Regulatory and Quality.
Key Responsibilities: Lead the Manufacturing Operations team supporting manufacturing and analytical activities including method qualification/validation, method transfer, establishing specifications and justification for specifications and stability protocols (clinical and commercial), data and reports. Also including laboratory release testing review.
Oversight of Aseptic processing, environmental monitoring program, technical transfers between development/GMP and site/site oversight including operator qualification and media run program including review of analytical method qualifications, transfer protocols and lab investigations
Interacts with the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions.
Oversight of equipment/facility/utility certifications, qualification and requalification program and when appropriate validation master plan.
Partner with CMC, Clinical, Regulatory, Quality and Nonclinical development functions to ensure GMP, GLP and GCP compliance at HebeCell Corporation.
Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
Education level and/or relevant experience required: Master’s degree and 8+ years of relevant work experience, or bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, and relevant comparable background in Cell Therapy Manufacturing Knowledge and skills (general and technical) preferred.
To apply, please submit your cover letter/ resume to: email@example.com